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					January 19, 2009

Ms. LouAnn Stanton
Office of the General Counsel
Department of Public Health
250 Washington Street
Boston, MA 02108

       Re:    Written Comments - Proposed 105 CMR 970.000, Pharmaceutical and
              Medical Device Manufacturer Conduct.

Dear Ms. Stanton:

       I am submitting these comments on the above-referenced proposed
regulations (the “Proposed Rules”) on behalf of the New England Biotech
Association (“NEBA”). As the regional policy and public affairs voice for the
biotechnology and biopharmaceutical community, NEBA represents state
biotech associations, companies, academic institutions, and other organizations
consisting of more than 600 entities.

        As an initial matter, we support the comments of our partners the
Massachusetts Biotechnology Council and the Biotechnology Industry
Organization, which share our concerns over the breadth and reach of the
governing statute at M.G.L. c. 111N (the “Act”), as well as the many ambiguities
it introduces. We are also mindful of the resulting challenges faced by the
Department in officially interpreting this law. Nonetheless, once the Department
promulgates the Proposed Rules in accordance with this difficult legislative
mandate, the Massachusetts biopharmaceutical industry will face the most
comprehensive and onerous regulatory environment in the nation. While we
remain concerned about the impact of such sweeping and radical rules here in
Massachusetts, there will undoubtedly be a ripple effect across New England.
Therefore, we urge you to adopt the following amendments to the Proposed
Rules that, that in our view, will help mitigate the negative impact of this law on
the New England biotechnology sector.

   New England Biotech Association, 401 Edgewater Place, Suite 600, Wakefield, MA 01880
                       781.876.8844 /
Ms. LouAnn Stanton
January 19, 2009
Page 2

        First, we support the Department’s election to interpret the disclosure
requirements of Section 6 of the Act as limited to “sales and marketing
activities.” 105 CMR 970.009.1. In our view, such a clarification is consistent
with the intent and scope of the Act. We recommend, however, that the
Department further clarify that the definition of “sales and marketing activities”
excludes certain expenditures that are in fact not related to sales and marketing.
These include, for example, prescription drug rebates and discounts, free
samples of prescription drugs intended to be used by patients, patient assistance
programs, and contractual business transactions for patient services. Such an
amendment would align Massachusetts disclosure requirements with those
adopted in several other states.

        Second, we remain concerned about the Department’s apparent intent to
apply the Proposed Rules to physician interactions occurring outside of
Massachusetts. In our view, such an interpretation is unduly burdensome on
companies participating in activities outside of this state, and also inconsistent
with the intent of the Act. Applying the Department’s interpretation, covered
companies participating in events outside of this state will be responsible for
identifying Massachusetts physicians for the purpose of complying with the
uniquely stringent and comprehensive Massachusetts rules. Needless to say,
this process would raise numerous and difficult challenges despite our members’
best efforts and intentions for compliance. Moreover, in our view the language
of the Act signals the Legislature’s intent to limit its scope to activity within the
Commonwealth. See M.G.L. c. 111N, § 1 (defining pharmaceutical or medical
device marketers as those operating “in the Commonwealth.”). Consistent with
this language, the Proposed Rules should similarly apply only to covered
activities taking place in Massachusetts. We urge the Department to adopt and
clarify this limitation consistent with the intent of the Act.

       Third and finally, the Proposed Rules do not provide sufficient guidance
with respect to the calculation of the $50 threshold for reporting. 105 CMR
970.009.1. There is, for example, no indication as to whether this limitation is
based on a single expenditure, or instead is to be calculated cumulatively per
annum. In our view, the plain language of the Act requires that the limitation be
applied per single expenditure. Given the complications that will undoubtedly

   New England Biotech Association, 401 Edgewater Place, Suite 600, Wakefield, MA 01880
                       781.876.8844 /
Ms. LouAnn Stanton
January 19, 2009
Page 3

be associated with an already burdensome reporting requirement, we urge the
Department to so clarify the Proposed Rules.

       We appreciate the opportunity to share NEBA’s concerns with the
Proposed Rules. We look forward to working with the Department and the
Administration on policies that will continue to ensure New England remains a
global leader in the life sciences.


Paula Newton
Chair, New England Biotech Association

cc:       Secretary Judy Ann Bigby, Executive Office of Health & Human Services,
          Commonwealth of Massachusetts
          Commissioner John Auerbach, Department of Public Health, Commonwealth of Massachusetts
          David Morales, Deputy Chief of Staff, Office of the Governor, Commonwealth of Massachusetts

      New England Biotech Association, 401 Edgewater Place, Suite 600, Wakefield, MA 01880
                          781.876.8844 /